Viewing Study NCT01674543



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Study NCT ID: NCT01674543
Status: COMPLETED
Last Update Posted: 2014-08-12
First Post: 2012-08-22

Brief Title: Clinical Symptoms of Schizophrenia and Physical Exercise
Sponsor: Federal University of São Paulo
Organization: Federal University of São Paulo

Study Overview

Official Title: Schizophrenia and Physical Exercise Effect of 20 Weeks of Training in Symptoms and Concentration in Serum IGF-1 and BDNF
Status: COMPLETED
Status Verified Date: 2014-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Schizophrenia is a severe mental illness of psychosis being the most prevalent in society affecting 1 of the population The treatment of schizophrenia is basically done with antipsychotic drugs although other non-pharmacological interventions such as exercise a form of treatment seems to be considered Among the most recommended exercise for the general population the investigators highlight the aerobic and resistance exercises However few studies have reported the positive effect of aerobic exercise in the pathogenesis of schizophrenia In relation to resistance exercise and concurrent training it is unknown if the effect in patients with the disease especially when one considers the junction of the two types of exercises in the same training session called concurrent training However it is known through clinical studies and animal models that exercise modifies the brain improves neuroplasticity the mental condition of the individual frames and reverses neurodegeneration Associated with improvement in schizophrenia few clinical trials of aerobic exercise showed improvement in disease symptoms reducing anxiety and depression and clinical global improvement The hypothesis is that the types of proposed training resistance training and concurrent training can improve clinical symptoms of the disease and improve the side effects caused by drugs It is believed that the clinical changes are accompanied by increased serum IGF-1 by resistance training and aerobic training by BDNF
Detailed Description: Schizophrenia is a serious mental disease characterized by a combination of positive and negative symptoms and it is associated with social and occupational dysfunction The positive symptoms reflect an excess or distortion of normal functions delusions hallucinations and disorganized behavior whereas the negative symptoms are related to flattened affect alogia avolition and decreased cognitive function One recent study reported that schizophrenia is associated with distortions of reality changes in perceptions and thoughts difficulties in social situations and problems with daily functions

Schizophrenia generally appears at the end of adolescence or at the beginning of adulthood and affects approximately 1 of the population The disease has a deteriorating course and does not involve large neurological changes Its etiology may be explained by interactions between factors associated with genetic susceptibility and adverse environmental factors Recently it has been hypothesized that alterations in neuroplasticity may be an important factor for the development of schizophrenia

IGF-1 is an important growth factor that induces neuroplasticity neuronal survival cell differentiation cell proliferation synaptic plasticity and neurogenesis Schizophrenic patients have lower serum IGF-1 levels than healthy individuals Because IGF-1 levels are lower in schizophrenic patients and this is associated with the etiology of the disease it is important to investigate treatments that may increase serum IGF-1 Antipsychotic drugs such as olanzapine stimulate the phosphorylation of AKT which is part of the main downstream pathway of IGF-1 It is possible to activate AKT through several intracellular signals and receptors including activation of the insulin receptor IR However activation of the IGF-1 receptor IGF-1R appears to be the main activator of AKT phosphorylation

In addition to antipsychotic medications resistance exercises may be another way to increase IGF-1 concentrations This type of physical exercise has been growing in popularity in society In recent years evidence has shown benefits from this exercise for different age groups in both healthy and sick individuals and it has been indicated to augment bone mineral mass strength and muscular mass to prevent or treat sarcopenia to decrease frailty and functional impairment and to improve cognitive function and hypertension among other benefits

Studies conducted with the young and the elderly who underwent resistance training have shown increased serum IGF-1 levels However studies showing the effects of resistance training and concurrent training on schizophrenia and serum IGF-1 levels have not been performed Studying physical exercise is important for several reasons Importantly it is a low-cost treatment that may be a possible therapeutic tool not only to increase IGF-1 concentrations but also to decrease disease symptoms especially negative symptoms and the side effects of antipsychotic drugs extrapyramidal effects weight gain and tiredness which may improve quality of life Therefore the aim of this study is to evaluate the effects of 20 weeks of resistance training and concurrent training on psychotic and depressive symptoms quality of life and serum IGF-1 concentration

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None